Trial Outcomes & Findings for Study Of MK-0752 In Combination With Tamoxifen Or Letrozole to Treat Early Stage Breast Cancer (NCT NCT00756717)

NCT ID: NCT00756717

Last Updated: 2019-09-04

Results Overview

The number of participants experiencing at least one adverse event during the 24-day observation period and initial post-operative visit.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 22 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2019-09-04

Participant Flow

Participant milestones

Measure	MK-0752 Oral gamma-secretase inhibitor drug MK-0752, 350 mg for three days, four days off, then three days on, over a period of 10 days MK-0752: Women who are post menopausal will receive letrozole 2.5 mg by mouth one time per day for 24 days. Women who are pre menopausal, or who have a contraindication to letrozole will receive tamoxifen 20 mg orally one time per day for a period of 24 days. Starting on day 15 of this 24 day period all patients will receive the oral gamma-secretase inhibitor drug MK-0752 at a dose of 350 mg for three days on, then off four days, then three days on, for a total of 6 doses over a period of 10 days.
Overall Study STARTED	22
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure

MK-0752 Oral gamma-secretase inhibitor drug MK-0752, 350 mg for three days, four days off, then three days on, over a period of 10 days MK-0752: Women who are post menopausal will receive letrozole 2.5 mg by mouth one time per day for 24 days. Women who are pre menopausal, or who have a contraindication to letrozole will receive tamoxifen 20 mg orally one time per day for a period of 24 days. Starting on day 15 of this 24 day period all patients will receive the oral gamma-secretase inhibitor drug MK-0752 at a dose of 350 mg for three days on, then off four days, then three days on, for a total of 6 doses over a period of 10 days.

Overall Study Withdrawal by Subject

2

Baseline Characteristics

Study Of MK-0752 In Combination With Tamoxifen Or Letrozole to Treat Early Stage Breast Cancer

Baseline characteristics by cohort

Measure	MK-0752 n=20 Participants Oral gamma-secretase inhibitor drug MK-0752, 350 mg for three days, four days off, then three days on, over a period of 10 days MK-0752: Women who are post menopausal will receive letrozole 2.5 mg by mouth one time per day for 24 days. Women who are pre menopausal, or who have a contraindication to letrozole will receive tamoxifen 20 mg orally one time per day for a period of 24 days. Starting on day 15 of this 24 day period all patients will receive the oral gamma-secretase inhibitor drug MK-0752 at a dose of 350 mg for three days on, then off four days, then three days on, for a total of 6 doses over a period of 10 days.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

The number of participants experiencing at least one adverse event during the 24-day observation period and initial post-operative visit.

Outcome measures

Measure	MK-0752 n=20 Participants Oral gamma-secretase inhibitor drug MK-0752, 350 mg for three days, four days off, then three days on, over a period of 10 days MK-0752: Women who are post menopausal will receive letrozole 2.5 mg by mouth one time per day for 24 days. Women who are pre menopausal, or who have a contraindication to letrozole will receive tamoxifen 20 mg orally one time per day for a period of 24 days. Starting on day 15 of this 24 day period all patients will receive the oral gamma-secretase inhibitor drug MK-0752 at a dose of 350 mg for three days on, then off four days, then three days on, for a total of 6 doses over a period of 10 days.
Number of Participants Experiencing at Least One Adverse Event At least one adverse event	15 Participants
Number of Participants Experiencing at Least One Adverse Event No Adverse Events	5 Participants

Adverse Events

MK-0752

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	MK-0752 n=20 participants at risk Oral gamma-secretase inhibitor drug MK-0752, 350 mg for three days, four days off, then three days on, over a period of 10 days MK-0752: Women who are post menopausal will receive letrozole 2.5 mg by mouth one time per day for 24 days. Women who are pre menopausal, or who have a contraindication to letrozole will receive tamoxifen 20 mg orally one time per day for a period of 24 days. Starting on day 15 of this 24 day period all patients will receive the oral gamma-secretase inhibitor drug MK-0752 at a dose of 350 mg for three days on, then off four days, then three days on, for a total of 6 doses over a period of 10 days.
General disorders Mild hot flashes	40.0% 8/20 • Number of events 8 • Adverse event data were collected for 30 days
General disorders Grade 1 Pelvic heaviness & vaginal discharge	5.0% 1/20 • Number of events 1 • Adverse event data were collected for 30 days
General disorders Grade 1 peri-orbital edema and cough	5.0% 1/20 • Number of events 1 • Adverse event data were collected for 30 days
General disorders Grade 1 acneiform facial rash	20.0% 4/20 • Number of events 4 • Adverse event data were collected for 30 days
General disorders Self-limiting nausea, vomiting, and headaches	5.0% 1/20 • Number of events 1 • Adverse event data were collected for 30 days

Additional Information

Dr. Kathy Albain

Loyola University Medical Center

Phone: 708-327-3102

Email: KALBAIN@lumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place